医疗保健中的人工智能需要总编辑吗? 真正的人类监督的一个领先的例子
1Faculty of Medicine and Health Sciences, University of Ghent Corneel Heymanslaan 10, 9000 Ghent Belgium.
European journal of health law
|December 17, 2025
概括
医疗保健中的高风险人工智能 (AI) 需要强有力的治理. 医院需要机构范围内的AI监督结构,而不仅仅是程序合规,以确保安全和问责制.
科学领域:
- 医疗保健人工智能的人工智能
- 医学伦理 医学伦理
- 监管合规性 监管合规性
背景情况:
- 高风险的人工智能 (AI) 在医疗保健中的整合提供了效率,但也带来了安全和问责制的挑战.
- 欧盟的人工智能法规定了对医疗保健人工智能的人类监督,创造了监管要求.
- 目前的法规缺乏对人工智能监督的持续责任的明确性,风险是分散的问责制和潜在的危害.
研究的目的:
- 根据欧盟人工智能法,分析实施高风险医疗人工智能的人类监督的模两可.
- 为有效监督提出一个系统性的,全机构的AI治理模型.
- 倡导从"循环中的人类"转向多学科AI治理委员会.
主要方法:
- 分析欧盟的人工智能法案,特别是第14条和第26条.
- 在医疗机构对人工智能治理的概念框架开发.
- 对监督模型的比较分析,包括"人与人"和AI治理委员会.
主要成果:
- 在分配供应商,部署者和临床医生之间持续的AI监督责任方面存在重大法律和运营模糊性.
- 单纯遵守程序是不够的;系统性的,全机构的治理结构是必要的,以提供知情和持续的监督.
- 建议建立一个多学科的人工智能治理委员会模型,以平衡法律职责,道德责任和专业自主权.
结论:
- 在医疗保健中有效的AI监督需要正式的,机构范围的治理结构,而不仅仅是简单的程序合规性.
- 医院必须制定明确的角色,政策和培训,以赋予人工智能识字能力和权威的人类监督员.
- 多学科人工智能治理委员会对于确保人工智能增强临床判断和患者倡导,同时满足监管要求至关重要.
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